The following genetic and protein biomarkers for the diagnosis of prostate cancer are considered investigational:
Kallikrein markers (eg, 4Kscore Test)
Prostate Health Index (phi)
HOXC6 and DLX1 testing (eg, SelectMDx)
PCA3, ERG, and SPDEF RNA expression in exosomes (eg, ExoDx Prostate IntelliScore)
Autoantibodies ARF 6, NKX3-1, 5′ -UTR-BMI1, CEP 164, 3′ -UTR-Ropporin, Desmocollin, AURKAIP-1, and CSNK2A2 (eg, Apifiny)
PCA3 testing (eg, Progensa PCA3 Assay)
TMPRSS:ERG fusion genes (eg, MyProstate Score)
Gene hypermethylation testing (eg, ConfirmMDx)
Mitochondrial DNA variant testing (eg, Prostate Core Mitomics Test)
PanGIA Prostate
Candidate gene panels.
Single nucleotide variant testing for cancer risk assessment of prostate cancer is considered investigational.
